Biomapas

🌟It is only the first day of BIOPLUS-INTERPHEX KOREA (BIX), and our CEO, János Filakovský, is already diving into the thick of it. This afternoon he participated in the panel discussion ‘Regulatory Affairs for Clinical Trials in Europe’, exploring the clinical trial infrastructure in Europe.🌍 János talked about harmonised clinical trial approval processes in the EU, and Biomapas’ experience navigating the new Clinical Trials Information System (CTIS). He examined individual start-up strategies, rapid patient enrolment, and collaborations with Korean Biotechs, and discussed the cultural differences between APAC and Europe. Additionally, he highlighted how the landscape of Eastern European trial sites has changed in recent years despite historical hesitation to include sites in the region. If you are interested in exploring these topics further with János, or have any other questions, don't hesitate to find him at the conference over the next few days or reach out via the BIX partnering platform.🤝 #InterphexKorea2024 #ClinicalTrialsEurope #LithuaniaCRO #BiotechCollaboration #KoreaBIO

🔍In our recent webinar, we explored leveraging technology for more efficient Pharmacovigilance and Medical Information processes. On that note, today, we are featuring a blog post on partial validation in drug safety systems.📝 Within the evolving landscape of Computer System Validation (CSV), each upgrade demands careful scrutiny. This article delves into the complexities of partial validation, influenced by factors like: - System complexity - Risk assessments - New functionalities As we dive into the article, we will explore these aspects through a case study, focusing on validating a new feature for a major safety database from a mid-sized EU CRO, updates to key documentation, and risk assessments. ✨Discover more insights and best practices in CSV: https://lnkd.in/e79avWJr ✨If you are curious about PV/MI technologies, why not watch our recent webinar recording: https://lnkd.in/ePJwHzay #DrugSafety #Pharmacovigilence #CSV #RiskAssessment

Exploring the secrets of botany! We are celebrating summer with a sprinkle of competition. Or, to be precise, we’ve spent a couple of hours exploring the Botanical Gardens, playing a little orientational game to discover the most mysterious spots, and learning exciting facts about exotic plants. These activities are part of our tradition – B Active, as we call it. It’s a way for us to dedicate time to activities that encourage movement, both of the body and the mind. And so, on Wednesday, we finished our day by strolling through rivers of flowers, savouring the sweet scents and enjoying a break in summer’s heat. Many smiles have been captured, and we are sure many more will bloom as we strive to learn something new and reach for more every day. #team #botany #exploration

🌟Such an engaging time we had yesterday! A huge shoutout to all who joined us for the ‘Breaking Silos Across Medical Information & Pharmacovigilance’ webinar!🙌 During this insightful session, we explored how technology can optimise Medical Information & Pharmacovigilance processes to enhance efficiency and collaboration. Olga Asimaki, PhD, CMD, Head of Global Medical Information, and Martijn van de Leur, Chief Operating Officer, guided us through examples for a Single Source of Truth (SSOT) PV/MI System, including handling Adverse Events, Product Quality Complaints, and MI inquiries.📊 Missed the webinar? We've got you covered – the recording is now available on YouTube to watch at your convenience. Discover how you can enhance your operational efficiency🔗: https://lnkd.in/ePJwHzay #PVMIWebinar #MedicalInformation #CROWebinar #PharmacovigilanceSSOT 

We started our Wednesday with a special breakfast this week! As part of our Bites & Insights tradition, we spent this morning informally conversing with our team of executives, who answered any burning questions our colleagues had about our people, goals, partnerships, and so much more. As the first word in our tradition says, we finished the breakfast by snacking on baked goods and chatting about our summer vacation plans, travel ideas, and a couple of upcoming events, such as who will join us in running a marathon and a velomarathon later this summer. Such periodic breakfasts are deeply ingrained in our culture, as we seek to stay aligned throughout our entire organisation and deepen our relationships with each other by spending time together. #team #breakfast #relationships

⏰Only 24 hours to go! – Join our webinar tomorrow to discover how to optimise intake from multiple channels while enhancing patient safety and compliance in Pharmacovigilance and Medical Information. Olga Asimaki, PhD, CMD, Head of Global Medical Information, and Martijn van de Leur, Chief Operating Officer, will walk you through strategies for a Single Source of Truth (SSOT) PV/MI System, handling Adverse Events, Product Quality Complaints, and MI inquiries!🚀 Ready to simplify your data management processes?🌟Secure your spot now: https://lnkd.in/eFvNnpRz #BiomapasWebinar #MedicalInformation #Pharmacovigilance #SSOTTechnology 

✨ Happy Monday! Why not kickstart a productive week by exploring the Fourth Edition of the Biomapas Bulletin?🗞   From the upcoming PV & MI technology webinar to reflections on key conferences like ASCO and BIO International, we are staying up to date with innovations in the life sciences industry. If you are looking for a deep dive, grab a cup of coffee and read our latest case study on specialised rescue studies in Georgia.🌍   #BiomapasBulletinJune #LifeSciencesNewsletter #CRO 

📢Exciting News! Biomapas CEO, János Filakovský, is attending and presenting at BIOPLUS-INTERPHEX KOREA (BIX) this July in Seoul! Janos will speak on the panel, ‘Regulatory Affairs for Clinical Trials in Europe’, covering Europe’s regulatory advantages, and new regulations introduced, aiming to further streamline clinical trials approval/authorisation process within the EU market.⚖️ The panel will discuss how Europe’s advanced clinical trial infrastructure and reasonable costs are making it an ideal destination for clinical trials. The session will explore the impact of new regulations, the competitive advantages Europe offers, and the financial incentives available.📈 BIX is a premier biopharmaceutical exhibition offering keynote sessions, conferences, and networking opportunities. Janos brings his extensive expertise in clinical research, regulatory compliance, and strategic growth into this dynamic event. Join Janos for a dive into the future of clinical trials in Europe. Don't miss the chance to connect and gain valuable insights! ✨Learn more about the session here: https://bit.ly/3RJ3mYU #BIXKorea2024 #Biopharmaceuticals #RegulatoryAffairs #LithuaniaCRO #KoreaBIO 

🚀Join our free webinar for practical insights on effective PV & MI data management, including handling Adverse Events, Product Quality Complaints, and MI inquiries! ✨ Discover how to:  - Integrate MI, AE, and PQC to enhance operational efficiency  - Implement standardised forms for improved data management  - Leverage MI for compliance and competitive edge  - Foster collaboration to streamline workflows and minimise disruptions Our experts, Olga Asimaki, PhD, CMD, Head of Global Medical Information, and Martijn van de Leur, Chief Operating Officer, will guide you through practical examples and effective solutions.    Secure your spot now👉bit.ly/PV-MI-Webinar #PVMIWebinar #MedicalInformation #CROWebinar #PharmacovigilanceTechnology  

Bidding Adieu to DIA 2024! The conference highlighted the industry’s dedication to patient-centric, collaborative, and diverse approaches. Read Roope Ghosh’s key takeaways below: 🔍 Regulatory Submissions – There is a crucial need for modernising clinical trials and regulatory approaches to accelerate treatment approvals, particularly for rare diseases. This would support ongoing efforts in innovation and streamlining processes in the industry. 🌐Diversity in Clinical Trials – Ongoing efforts are in place to ensure that medical research and innovations are inclusive and beneficial to diverse populations. Strategies discussed included improving diversity in trial participation and the broader healthcare workforce. 👩⚕️ Patient Centricity – A significant emphasis was placed on patient-centred care, with discussions on integrating patient perspectives into drug development and regulatory processes. 🤝 Collaborative Relations – The convention underscored the importance of collaboration among stakeholders, including industry professionals, regulators, researchers, and patients. This approach is crucial for addressing global health challenges and advancing scientific and medical innovations. At Biomapas, we are excited to see how these impactful discussions will be shaping the industry – Connect with Roope via LinkedIn for more insights! #DIA2024 #ClinicalInnovation #RegulatoryAdvancements #PatientCentricity